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510(k) rescissions limited to "compelling" cases pending reg's completion, FDA tells HIMA.

This article was originally published in The Gray Sheet

Executive Summary

510(K) RESCISSIONS WILL BE LIMITED TO FRAUD, HEALTH RISK, or "other compelling circumstances" until FDA finalizes a regulation on rescission procedures, the agency says in a Sept. 11 "interim response" to a Health Industry Manufacturers Association citizen's petition. The response upholds the agency's authority to rescind 510(k)s, which had been challenged by HIMA in the October 1994 petition ("The Gray Sheet" Oct. 31, 1994, p. 20).
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